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Online mindfulness-based intervention for women with post-mastectomy chronic pain

Effects of an online mindfulness intervention for women with chronic post-mastectomy pain: randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-10j9wjy5
Enrollment
Unknown
Registered
2021-01-06
Start date
2021-01-11
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasm

Interventions

The intervention group, with 50 participants, will be part of an 8-week online program based on mindfulness in the MBHP model (Mindfulness Based Health Promotion). The Control Group (50 participants)

Sponsors

Universidade Federal de São Carlos
Lead Sponsor
Universidade Federal de São Carlos
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Mastectomized women who have stopped treatments for at least 6 months; over 18 years; complaints of pain related to the surgical procedure for at least 6 months after surgery, measured with a score greater than or equal to three on a pain scale from 0 to 10; who have access to a computer, tablet or smartphone; who have access to the internet; availability to dedicate 2 hours a week for 8 weeks to participate in the intervention group.

Exclusion criteria

Exclusion criteria: Women with breast cancer recurrence, metastasis or any other type of cancer; severe psychiatric disorder and / or risk of suicide, or any type of dementia (self-report); current practice or in the last 6 months that includes contemplative states (yoga, meditation, mindfulness); other severe medical conditions related to the musculoskeletal or rheumatological system that are related to chronic pain conditions (example: fibromyalgia, osteoporosis, gout, bursitis, rheumatoid fever, rheumatoid arthritis, systemic lupus erythematosus and scleroderma, among others); who are unable to commit to the intervention.

Design outcomes

Primary

MeasureTime frame
Assess the degree of severity and interference of pain in daily life, which will be carried out through the Brief Pain Inventory (BPI - B), which will be applied before the intervention, up to one week after the intervention, and three months after the end of the intervention. intervention. The Inventory consists of 9 items arranged in two dimensions: pain intensity / severity (sensory dimension) and pain interference (impact) in the patient's life (reactive dimension). The participant will rate the intensity of their pain and assess the degree of pain interference in their daily life on an 11-point Likert scale, which ranges from 0 (no pain / no interference) to 10 (worst pain / interference that they can perceive ). The measurement of the variable will take place continuously.

Secondary

MeasureTime frame
Assess the degree of catastrophizing of pain, being measured by the Pain Catastrophizing Scale (PCS), which is a self-administered questionnaire with 13 items for the assessment of catastrophizing thoughts, covering 3 domains: helplessness, enlargement and rumination. Items are classified on a 5-point Likert scale, ranging from 0 to 4 (0-Never, 1-A few times, 2-Sometimes, 3-Often, 4-Always). The score of the domains is given by the sum of its items: helplessness questions 1, 5 and 12; magnifying questions 6.7 and 13; rumination 8 and 11. To calculate the total score, all items will be added, ranging from 0 to 52 points. The evaluation will take place before the intervention, shortly after its completion and 3 months after the intervention.;Assess the level of stress perceived by the participant, using the Stress Perception Scale (BPSS 10), in three moments: before the intervention, immediately after its completion and 3 months after the intervention. The BPSS-10 is a self-report scale composed of 10 items for the classification of the frequency of feelings and thoughts related to events and situations that occurred in the last month. Six items are negative and the rest are positive. Each item is evaluated on a 5-point Likert scale (from 1-never to 5-very often). The four positive items must receive a reverse score and then all the items are added together to obtain the total score, ranging from 0 to 40, with the higher the score the higher the stress level.;Assess the capacity of mindfulness, which will be measured by the Mindfulness Attention Awareness Scale (MAAS) in 3 moments: before the intervention, just after its end and 3 months after the intervention. MAAS is a self-report scale of 15 items that seeks to measure the level of attention and awareness with which the person experiences everyday situations, through the classification on a 6-point Likert scale, ranging from 1 (almost always) to 6 ( almost never).;To survey, evaluate and perceive relationships betw

Countries

Brazil

Contacts

Public ContactDaniela Souza
danielaxaviersouza@gmail.com+55-16-33518338

Outcome results

None listed

Source: REBEC (via WHO ICTRP)